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The evolution of reperfusion therapy in acute myocardial infarction and acute ischaemic stroke has many similarities: thrombolysis is superior to
placebo, intra-arterial thrombolysis is not superior to intravenous (i.v.), facilitated intervention is of questionable value, and direct mechanical
recanalization without thrombolysis is proven (myocardial infarction) or promising (stroke) to be superior to thrombolysisbut only when
started with no or minimal delay. However, there are also substantial differences. Direct catheter-based thrombectomy in acute ischaemic
stroke is more difficult than primary angioplasty (in ST-elevation myocardial infarction [STEMI]) in many ways: complex pre-intervention diagnostic workup, shorter time window for clinically effective reperfusion, need for an emergent multidisciplinary approach from the first
medical contact, vessel tortuosity, vessel fragility, no evidence available about dosage and combination of peri-procedural antithrombotic
drugs, risk of intracranial bleeding, unclear respective roles of thrombolysis and mechanical intervention, lower number of suitable patients,
and thus longer learning curves of the staff. Thus, starting acute stroke interventional programme requires a lot of learning, discipline, and humility.
Randomized trials comparing different reperfusion strategies provided similar results in acute ischaemic stroke as in STEMI. Thus, it might be
expected that also a future randomized trial comparing direct (primary) catheter-based thrombectomy vs. i.v. thrombolysis could show superiority of the mechanical intervention if it would be initiated without delay. Such randomized trial is needed to define the role of mechanical intervention alone in acute stroke treatment.
----------------------------------------------------------------------------------------------------------------------------------------------------------Keywords
Introduction
Acute regional ischaemia with progressive necrosis developing
quickly during the initial hours after arterial thrombotic occlusion is
a common feature of acute myocardial infarction and acute ischaemic
stroke. Both these diseases are leading causes of death worldwide.
Restoration of antegrade blood flow in the acutely occluded artery
(i.e. reperfusion of the ischaemic tissue) is the most effective
therapy in both situations (Figures 1 and 2). Timely reperfusion
halts the progress of necrosis and preserves viable tissue (myocardium in jeopardy or cerebral penumbra).
The pathophysiology of cerebral infarction is different from myocardial infarction. Whereas in myocardial infarction thrombotic arterial occlusion over the ruptured coronary plaque can be found in
90 95% of patients, acute stroke in many patients cannot be
simply attributed to a cerebral vessel occlusion (e.g. lacunar cerebral
infarction has completely different aetiology). The differences
between these two diseases are at least as important as the similarities, and the treatment should be done by physicians having these differences in mind (Table 1).
Reperfusion therapy of acute myocardial infarction using
thrombolytic agents was first used by Chazov et al.1 in 1976 and
* Corresponding author. Tel: +420 267163159, Fax: +420 267162621, Email: petr.widimsky@fnkv.cz
& The Author 2013. Published by Oxford University Press on behalf of the European Society of Cardiology.
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/), which
permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact
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Received 29 May 2013; revised 18 August 2013; accepted 13 September 2013; online publish-ahead-of-print 3 October 2013
148
P. Widimsky et al.
infarction [STEMI] (two acutely occluded coronary arteries). (A) Thrombotic occlusion of the proximal right coronary artery on admission. (B)
Widely patent (near-normal) right coronary artery after stent implantation. (C) Thrombotic occlusion of the proximal obtuse marginal branch
on admission. (D) Widely patent (near-normal) obtuse marginal branch after stent implantation.
Figure 2 Carotid angiography before and after catheter-based thrombectomy in acute anterior circulation stroke. (A) Thrombotic occlusion of
the middle cerebral artery on admission. (B) Widely patent (near-normal) middle cerebral artery after catheter-based thrombectomy.
Figure 1 Coronary angiography before and after primary percutaneous coronary intervention in a patient with double ST-elevation myocardial
149
Table 1
Similarities and differences between acute myocardial infarction and acute stroke
Acute myocardial infarction
Pathophysiology
Clinical picture
Prognosis
Acute onset
High mortality (if untreated by reperfusion)
Acute onset
High mortality and permanent disability
Effective treatment
Reperfusion therapy
Reperfusion therapy
Aetiology
3 h (8 h in some patients)
Reperfusion damage
Clinical picture
None
.90%
,10%
...............................................................................................................................................................................
Similarities
...............................................................................................................................................................................
Differences
was introduced into broad clinical practice 10 years later after the
publication of the pivotal randomized clinical trials GISSI2 and
ISIS-2.3 Mechanical recanalization by means of primary angioplasty
was first used by Meyer et al.4 and Hartzler et al.5 The first three randomized clinical trials showing superiority of primary PTCA over
thrombolysis in ST-elevation myocardial infarction [STEMI] were
published by Zijlstra et al.,6 Grines et al.,7 and Gibbons et al.8 in
1993. It took another 9 years before the Czech Society of Cardiology
published the worlds first official guidelines recommending primary
angioplasty as the first-choice therapy for STEMI.9
The history of reperfusion therapy in acute ischaemic stroke is
even more complicated. The first attempts to treat acute stroke by
thrombolysis were reported in 1976.10 The first small randomized
trial showing potential benefits of thrombolysis when used early in
acute stroke was published in 1992,11 and in 1995 the first positive
randomized trial of thrombolysis was published.12 The first official
guidelines recommending thrombolysis for acute stroke were published in 2003.13 Direct mechanical reperfusion using catheter-based
thrombectomy without thrombolysis was first used in 2001,14 and
there is yet no randomized trial completed to date comparing
mechanical reperfusion (without thrombolysis) vs. intravenous
(i.v.) thrombolysis. Thus, the latest official guidelines15 do not yet
recognize direct mechanical intervention as the accepted routine
therapy for acute stroke.
150
Figure 3 Comparison of intravenous thrombolysis vs. placebo in acute myocardial infarction and acute stroke. (A) Hard clinical endpoints, i.e.
death/re-infarction/stroke for STEMI patients and death/severe disability (modified Rankin Scale [mRS] . 2) for stroke patients. (B) All-cause mortality. (C) Symptomatic intracranial haemorrhage. Adopted from references 3,12, and 22.
P. Widimsky et al.
151
Many randomized trials in STEMI36 39 and others tested the attractive hypothesis: to use i.v. thrombolysis at the time of first medical
contact (to save time), followed by coronary angiography and angioplasty (to maximize the recanalization rates) (Figures 5 and 6).
However, all these trials failed to show benefit of this approach
over direct angioplasty alone. The results of most trials almost
copied the two similarly designed three-arm trials28,36: facilitated
angioplasty was slightly superior to i.v. thrombolysis alone, but was
far less effective than primary angioplasty alone. The explanation is
complex, but most important are two differences favouring
Facilitated intervention
(thrombolysis 1 mechanical
intervention)
152
P. Widimsky et al.
i.e. death/re-infarction/stroke for STEMI patients and death/severe disability (mRS . 2) for stroke patients. (B) All-cause mortality. (C) Symptomatic
intracranial haemorrhage. Adopted from references 24 26 and 29.
Primary catheter-based
intervention (primary
percutaneous coronary
intervention, direct catheter-based
thrombectomy)
The benefits of primary PCI over thrombolysis in STEMI were clearly
demonstrated 20 years ago (Figure 7).6 8 These benefits are present
even when patients require transportation from the first medical
contact site to the nearest PCI-capable hospital.41,42 A large
meta-analysis has demonstrated this benefit unequivocally.43
Figure 4 Comparison of intra-arterial vs. intravenous thrombolysis in acute myocardial infarction and acute stroke. (A) Hard clinical endpoints,
153
Figure 7 Comparison of catheter intervention alone vs. intravenous thrombolysis alone in acute myocardial infarction and acute
stroke. Adopted from reference 43 (STEMI); no randomized trials
available for acute stroke.
Figure 5 Comparison of intravenous thrombolysis vs. lysis-facilitated intervention in acute myocardial infarction and acute stroke. (A) Hard clinical endpoints, i.e. death/re-infarction/stroke for STEMI patients and death/severe disability (mRS . 2) for stroke patients. (B) All-cause mortality. (C)
Symptomatic intracranial haemorrhage. Adopted from references 28,36, and 40.
154
Similar evidence from randomized trials is lacking in acute ischaemic stroke. A few years ago, CBT was performed with bulky devices,
and a significant risk of complications was present. In the last 35
years, several new clot retrieval devices (stent retrievers) have
been introduced and received CE mark for the use in European
patients. These devices (e.g. Solitairew or Trevow) are something
between a tiny self-expanding stent and a soft spider-web-like
basket for clot removal, and the risks of complications with this
latest generation stent retrievers are much smaller, whereas their
success rates are higher. Detailed information about CBT was published in the JACC white paper.44
The Penumbra Pivotal Stroke Trial45 included 125 patients, mostly
pre-treated by thrombolysis, with a mean NIHSS of 17.6, and demonstrated an 81.6% of recanalization rate. However, clinical outcomes
were not different (or were even worse) from previous thrombolytic
trials: 32.8% 90-day mortality, 75% unfavourable outcome (death or
disability), and 11.2% sICH.
The Solitaire With the Intention For Thrombectomy (SWIFT)
trial46 tested the Solitairew stent retriever against the Merci Retrieverw in patients within 8 h of stroke onset but was stopped early after
the randomization of 113 patients because an interim analysis
showed that the primary efficacy outcome (TIMI 2 or 3 flow) was
achieved more often with Solitairew (61 vs. 24%, OR 4.87, P ,
0.0001).46 Importantly, good neurological outcome (58 vs. 33%,
OR 2.78, P 0.0001) and 90-day mortality (17 vs. 38%, OR 0.34,
P 0.0001) were more favourable in the Solitairew group with a
markedly lower rate of sICH (2 vs. 11%, OR 0.14, P 0.057).
The TREVO 2 trial47 was similar to SWIFT and tested the Trevow
stent retriever vs. The Merci Retrieverw. Recanalization (TICI 2 or
greater) was higher with Trevow than with Merciw (86 vs. 60%,
OR 4.22, P , 0.0001) as was good clinical outcome (40 vs. 22%,
OR 2.39, P 0.013). There were no differences in the risk of sICH
(7 vs. 9%, OR 0.75, P 0.78) or 90-day mortality (33 vs. 24%, OR
1.61, P 0.18). An important finding from the SWIFT trial was that
the speed of recanalization with the stent retrievers was significantly
lower (36 min with Solitairew vs. 52 min with Merciw, P 0.038).
Several other devices with varying designs are currently being tested.
A recently published single-centre experience48 with 104 patients
treated with the Solitairew stent retrieval, 75% of them received also
thrombolysis. The recanalization rate was 78%. The mean NIHSS
decreased from 15.3 (before) to 7.8 (after treatment). Mortality
was 16% (anterior circulation) and 47.8% (posterior circulation).
Intracranial bleeding occurred in 8%.
Another recent multicentre retrospective review49 included 237
patients (mean age 64 years; mean baseline NIHSS 15) with acute
proximal intracranial anterior circulation occlusionendovascular
treatment was initiated .8 h (mean 15 h) from time last seen well.
The treatment selection was strictly based on MRI or CT perfusion
imaging. Successful revascularization was achieved in 74%. Parenchymal haematoma occurred in 9%. The 90-day mortality rate was 21.5%
and unfavourable outcome was in 55%.
The most recent meta-analysis50 of CBT registries identified 16 eligible published studies: 4 on the Merci device (n 357), 8 on the Penumbra system (n 455), and 4 on stent retrievers Solitairew or
Trevow (n 113). The mean procedural duration for Merci was
120 min. The mean puncture-to-recanalization time for Penumbra
was 64.6 min, and for stent retrievers, 54.7 min. Successful
P. Widimsky et al.
155
Summary
The evolution of reperfusion therapy in acute myocardial infarction
and acute ischaemic stroke has many similarities: thrombolysis is superior to placebo, i.a. thrombolysis is not superior to i.v., facilitated
intervention (thrombolysis followed by mechanical intervention) is
of questionable value, and direct mechanical recanalization without
thrombolysis clearly is (myocardial infarction) or possibly will be
(stroke) superior to thrombolysisbut only when started with no
or minimal delay (Table 2).
However, there are also substantial differences. Direct catheterbased thrombectomy in acute ischaemic stroke is more difficult
than primary angioplasty (in STEMI) in many ways: complex preintervention diagnostic workup, shorter time window for clinically effective reperfusion, need for an emergent multidisciplinary approach
from the first medical contact, vessel tortuosity, vessel fragility, no
evidence available about dosage and combination of peri-procedural
antithrombotic drugs, risk of intracranial bleeding, unclear respective
roles of thrombolysis and mechanical intervention, lower number of
suitable patients, and thus longer learning curves of the staff. Thus,
starting acute stroke interventional programme requires a lot of
learning, discipline, and humility.
Reperfusion strategies combining thrombolysis with immediate
intervention (i.a. thrombolysis or i.v. thrombolysis followed by
STEMI
death/
re-MI/
stroke
Acute stroke
death/severe
disability
(mRs > 2)
1530%
1116%
55 75%
48 63%
1015%
51 60%
Facilitated intervention
(thrombolysis + intervention)
9 14%
59 79%
Primary catheter-based
intervention (no thrombolysis)
5 9%
No randomized
trials published
................................................................................
Funding
Preparation of this manuscript was supported by a research project of
Charles University Prague (PRVOUK P35).
Conflict of interest: none declared.
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